Well-Being Therapy by Personalized Mobile Technology Program for Psychological Distress and Promote Healthy Behaviors

Psychological Distress Clinical Trial

— WELL-ME  

Official title:

Well-Being Therapy for Psychological Distress and Enhancing Healthy Behaviors With Personalized Mobile Technology in Cardiac Patients: a Randomized Controlled-trial Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543815
• Other study ID #: NCT00289921
• Secondary ID: 029399
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: March 4, 2012
• Start date: January 2006
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: University of Bergamo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The WELL-ME study is a three-arm randomized controlled clinical trial (RCT). The aim of this RCT is to compare the effectiveness of the Well Being Web Based Therapy (WBT-Web) with the gold standard CBT (Cognitive Behavior Therapy) and standard clinical procedure of patients' management (CM) for psychological distress and promotion of healthy behaviors in Cardiac Patients.

Description:

Cardiac disease (CD) affects millions of European and Americans and new diagnosis rates are expected to almost triple over the next 30 years as our population ages. Affective disorders including clinical depression, anxiety and psychological distress are common in patients with CD. Furthermore, the presence of these disorders significantly impacts quality of life, adherence to medical prescription and healthy behaviors. The prevalence of depression, ranging from 11% to 25% among heart disease outpatients and 35% to 70% among those who are hospitalized. Psychological depression appears to be an important predictor of rehospitalization among persons who have been admitted with coronary artery disease. In addition, depression in patients with heart failure was found to be associated with the course of the disease and its prognosis. The high prevalence of psychological distress among the population of patients with heart failure, along with the broad impact on the patient's quality of life, requires attention to detail and the implementation of interventions aimed at reducing levels of distress. Very few studies describe interventions aimed at alleviating distress in patients with heart failure. Cognitive Behavioral Therapy (CBT) is reported to improve both the functional and emotional levels of these patients, resulting in the relief of their symptoms of depression. Recently Well Being Therapy WBT) have showed promising outcomes findings for depression and distress. There is a need to treat patients in their real life setting. Recent technological innovations in the ICT provide to monitor and treat the patient at a distance outside the hospital. The aim in this study is to study the effectiveness of the WBT-WEB in reducing psychological distress, and improving QoL, healthy behaviors and medical adherence in HR compared to a CBT and standard clinical procedure of patients' management (CM). The same protocol will be carried out in two centres (Hospital de Terrassa, Barcelona, Spain; National and Kapodistrian University of Athens, Greece). 300 patients diagnosed with cardiac disease, and with psychological distress, assessed by Hospital Anxiety and Depression Scale (HADS) will be randomized to one of three treatment groups: 1) WBT-WEB; 2) CBT and 3) CM. A one-year follow-up will be performed. It is expected that WBT-WEB may significantly decrease psychological distress and increase QoL, healthy behaviors and medical adherence at follow-up compared to clinical management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2010
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Cardiac Diseases

• a current diagnosis of at least one of the following: major or minor depression, dysthymia, anxiety according, to DSM-IV criteria, and HADS criteria

• Mini-Mental State Examination score higher than 24

• written informed consent provided by the patient to participate

Exclusion Criteria:

• uncertain prognosis for 12 months due to other conditions

• acute coronary disease in recent months.

• existence of another life-threatening illness of the patient (such as active cancer, chronic kidney failure).

• severe neurological problem (Brain syndrome / orientation problem/ difficult peripheral neuropathy).

• severe mental illness (active psychosis / suicide risk / severe dementia).

• linguistic limitations (such as stuttering / untreated audio impairment).

• a significant functional problem (such as unconsciousness / connection to respiration device / confined to a wheelchair or bed / severe walking disability / needs help with complete basic daily activities).

• objective limit that endangers liability for participation in the seven meetings (such as remote residential / tourist / convict / drug addict).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychological Distress

Intervention

Behavioral:
• Well-Being Therapy based on Web Mobile Technology
The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others.
• Cognitive Behavior Therapy
CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems.

Other:
• Standardized Care Management
CM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bergamo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological distress	Depression, Anxiety, and well-being improvements (Psychological Distress Reduction)	Within one year after the treatment	Yes
Secondary	Quality of Life	Quality of Life	Within one year after the treatment	Yes
Secondary	Medical Adherence		Within one year after the treatment	Yes
Secondary	Promotion of Healthy Lifestyle	Promotion of Healthy Lifestyle	Within one year after the treatment	Yes